Home NDC 63629-4284 Hydromorphone Hydrochloride
Product NDC 63629-4284
11-digit product format 636294284
Labeler code 63629
Product ID 63629-4284_07884a78-2a01-453c-870b-7b757b530d22
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydromorphone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA019892
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2009-11-23
Substance HYDROMORPHONE HYDROCHLORIDE
Active strength 2 mg/1
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019892-001 DILAUDID HYDROMORPHONE HYDROCHLORIDE 8MG TABLET / ORAL AB RLD, RS 1992-12-07 N019892-002 DILAUDID HYDROMORPHONE HYDROCHLORIDE 4MG TABLET / ORAL AB RLD 2007-11-09 N019892-003 DILAUDID HYDROMORPHONE HYDROCHLORIDE 2MG TABLET / ORAL AB RLD 2007-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 123 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019892-002 DILAUDID 4MG TABLET / ORAL AB RLD 2007-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019892-003 DILAUDID 2MG TABLET / ORAL AB RLD 2007-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019892-001 DILAUDID 8MG TABLET / ORAL AB RLD, RS 1992-12-07 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N019892-001 6589960 2020-11-09 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019892-002 6589960 2020-11-09 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019892-003 6589960 2020-11-09 Drug substance, Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N019892-001 6589960 2020-11-09 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019892-002 6589960 2020-11-09 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N019892-003 6589960 2020-11-09 Drug substance, Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019892-001 6589960 2020-11-09 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019892-002 6589960 2020-11-09 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N019892-003 6589960 2020-11-09 Drug substance, Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019892-001 6589960 2020-11-09 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019892-002 6589960 2020-11-09 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N019892-003 6589960 2020-11-09 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019892-001 6589960 2020-11-09 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019892-002 6589960 2020-11-09 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N019892-003 6589960 2020-11-09 Drug substance, Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019892-001 6589960 2020-11-09 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019892-002 6589960 2020-11-09 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N019892-003 6589960 2020-11-09 Drug substance, Drug product ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Hydromorphone Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROMORPHONE HYDROCHLORIDE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L960UP2KRW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 897696 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-4284-1 Hydromorphone Hydrochloride 25 in 1 BOTTLE TABLET 25 19 63629-4284-2 Hydromorphone Hydrochloride 60 in 1 BOTTLE TABLET 60 19 63629-4284-3 Hydromorphone Hydrochloride 30 in 1 BOTTLE TABLET 30 19 63629-4284-4 Hydromorphone Hydrochloride 28 in 1 BOTTLE TABLET 28 19 63629-4284-5 Hydromorphone Hydrochloride 90 in 1 BOTTLE TABLET 90 19 63629-4284-6 Hydromorphone Hydrochloride 120 in 1 BOTTLE TABLET 120 19 63629-4284-7 Hydromorphone Hydrochloride 40 in 1 BOTTLE TABLET 40 19 63629-4284-8 Hydromorphone Hydrochloride 20 in 1 BOTTLE TABLET 20 19 63629-4284-9 Hydromorphone Hydrochloride 10 in 1 BOTTLE TABLET 10 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-4284 HYDROMORPHONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] 19 Current NDC, Legacy NDC, 9 package rows 20250412_2427814c-f32b-8ac5-99b8-5e886fd2d001.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE Bryant Ranch Prepack 2427814c-f32b-8ac5-99b8-5e886fd2d001 2026-06-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019892 application number: NDA019892 ndc (product): 63629-4284 Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE St. Mary's Medical Park Pharmacy 53ddcacc-99e4-8b21-e063-6394a90a3e79 2026-06-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019892 application number: NDA019892 Dilaudid HYDROMORPHONE HYDROCHLORIDE Rhodes Pharmaceuticals LLC d6b40e39-a57e-402c-b4f6-7041e832f837 2026-05-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019892 application number: NDA019892 Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE Rhodes Pharmaceuticals LLC 37565441-0d95-4743-a695-d7b3326f58a1 2026-05-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019892 application number: NDA019892 Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE Bryant Ranch Prepack c48e2e9a-cb5b-46b8-b6be-3dd76e80d0ca 2026-04-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019892 application number: NDA019892 Hydromorphone Hydrochloride HYDROMORPHONE HYDROCHLORIDE ASCLEMED USA INC. 18f6f54e-1537-4181-9d07-54ddf881a9ee 2025-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019892 application number: NDA019892
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-4284-1 63629428401 25 TABLET in 1 BOTTLE (63629-4284-1) 25 tablet 2010-06-21 0000-00-00 No No Current 63629-4284-2 63629428402 60 TABLET in 1 BOTTLE (63629-4284-2) 60 tablet 2011-08-23 0000-00-00 No No Current 63629-4284-3 63629428403 30 TABLET in 1 BOTTLE (63629-4284-3) 30 tablet 2010-10-22 0000-00-00 No No Current 63629-4284-4 63629428404 28 TABLET in 1 BOTTLE (63629-4284-4) 28 tablet 2010-11-12 0000-00-00 No No Current 63629-4284-5 63629428405 90 TABLET in 1 BOTTLE (63629-4284-5) 90 tablet 2014-06-11 0000-00-00 No No Current 63629-4284-6 63629428406 120 TABLET in 1 BOTTLE (63629-4284-6) 120 tablet 2012-06-25 0000-00-00 No No Current 63629-4284-7 63629428407 40 TABLET in 1 BOTTLE (63629-4284-7) 40 tablet 2014-01-27 0000-00-00 No No Current 63629-4284-8 63629428408 20 TABLET in 1 BOTTLE (63629-4284-8) 20 tablet 2012-05-01 0000-00-00 No No Current 63629-4284-9 63629428409 10 TABLET in 1 BOTTLE (63629-4284-9) 10 tablet 2020-08-24 0000-00-00 No No Current